Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals

Alépée, Nathalie; Leblanc, Virginie; Adriaens, Els; Grandidier, Marie-Hélène; Lelièvre, Damien; Méloni, Marisa; Nardelli, L; Roper, Clive; Santirocco, E.; Toner, Frank; Rompay, An R. Van; Vinall, J.L.; Cotovio, José

doi:10.1016/j.tiv.2015.11.012

Cited by 41 publications

(28 citation statements)

References 10 publications

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“…Consequently, exposure to the substrates and/or inhibitors of ABC efflux proteins may increase the apparent viability of cells in the MTT assay thereby underestimating the cellular toxicity. Furthermore, other physical or chemical characteristics such as the color of the drug or the ability to reduce used substrate can interfere with toxicity experiments and thus give incorrect results [129]. …”

Section: Toxicity Tests With Corneal Cell Culture Modelsmentioning

confidence: 99%

“…Later, transferability, reproducibility, and predictive capacity of this model were investigated in studies performed in three laboratories using both liquids and solids [129, 143]. The overall accuracy of the model was 83.7 % (200 chemicals), specificity 72.1 % (103 chemicals), and sensitivity of 95.2 % (97 chemicals) [143].…”

Section: Toxicity Tests With Corneal Cell Culture Modelsmentioning

confidence: 99%

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Human corneal cell culture models for drug toxicity studies

Rönkkö

Vellonen

Järvinen

et al. 2016

Drug Deliv. and Transl. Res.

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In vivo toxicity and absorption studies of topical ocular drugs are problematic, because these studies involve invasive tissue sampling and toxic effects in animal models. Therefore, different human corneal models ranging from simple monolayer cultures to three-dimensional models have been developed for toxicological prediction with in vitro models. Each system has its own set of advantages and disadvantages. Use of non-corneal cells, inadequate characterization of gene-expression profiles, and accumulation of genomic aberrations in human corneal models are typical drawbacks that decrease their reliability and predictive power. In the future, further improvements are needed for verifying comparable expression profiles and cellular properties of human corneal models with their in vivo counterparts. A rapidly expanding stem cell technology combined with tissue engineering may give future opportunities to develop new tools in drug toxicity studies. One approach may be the production of artificial miniature corneas. In addition, there is also a need to use large-scale profiling approaches such as genomics, transcriptomics, proteomics, and metabolomics for understanding of the ocular toxicity.

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Section: Toxicity Tests With Corneal Cell Culture Modelsmentioning

confidence: 99%

Section: Toxicity Tests With Corneal Cell Culture Modelsmentioning

confidence: 99%

Human corneal cell culture models for drug toxicity studies

Rönkkö

Vellonen

Järvinen

et al. 2016

Drug Deliv. and Transl. Res.

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“…To improve the predictive capacity, the SkinEthic ™ HCE test method was revised into two independent methods for liquids and solids. For the Eye Irritation Testing of Liquids (EITL protocol), substances were treated for 30 min and then soaked in immersion media for 30 min and incubated for 30 min (72). Eye Irritation Testing of Solids (EITS protocol) adopts 4 hr treatment, and 18 hr post-incubation time (72).…”

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

“…For the Eye Irritation Testing of Liquids (EITL protocol), substances were treated for 30 min and then soaked in immersion media for 30 min and incubated for 30 min (72). Eye Irritation Testing of Solids (EITS protocol) adopts 4 hr treatment, and 18 hr post-incubation time (72). EITL and EITS exhibit the accuracy of 84.8% and 84.4%, specificity of 69.4% and 76.6%, and sensitivity of 98.3% and 92.2%, respectively (71,72).…”

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

2017

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Human eyes and skin are frequently exposed to chemicals accidentally or on purpose due to their external location. Therefore, chemicals are required to undergo the evaluation of the ocular and dermal irritancy for their safe handling and use before release into the market. Draize rabbit eye and skin irritation test developed in 1944, has been a gold standard test which was enlisted as OECD TG 404 and OECD TG 405 but it has been criticized with respect to animal welfare due to invasive and cruel procedure. To replace it, diverse alternatives have been developed: (i) For Draize eye irritation test, organotypic assay, in vitro cytotoxicity-based method, in chemico tests, in silico prediction model, and 3D reconstructed human cornea-like epithelium (RhCE); (ii) For Draize skin irritation test, in vitro cytotoxicity-based cell model, and 3D reconstructed human epidermis models (RhE). Of these, RhCE and RhE models are getting spotlight as a promising alternative with a wide applicability domain covering cosmetics and personal care products. In this review, we overviewed the current alternatives to Draize test with a focus on 3D human epithelium models to provide an insight into advancing and widening their utility.

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“…The HCE cell line model, made of immortalized epithelial cells by SV40 is provided by SkinEthic and used for ocular toxicity studies as monolayer studies [7] and 3D models [8]. However, this cell line expresses, in addition to corneal markers found in vivo, markers of simple epithelia [5].…”

Section: Introductionmentioning

confidence: 99%

Induced pluripotent stem cell-derived limbal epithelial cells (LiPSC) as a cellular alternative for in vitro ocular toxicity testing

et al. 2017

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Induced pluripotent stem cells hold great potential to produce unlimited amount of differentiated cells as cellular source for regenerative medicine but also for in vitro drug screening and cytotoxicity tests. Ocular toxicity testing is mandatory to evaluate the risks of drugs and cosmetic products before their application to human patients by preventing eye irritation or insult. Since the global ban to use animals, many human-derived alternatives have been proposed, from ex-vivo enucleated postmortem cornea, primary corneal cell culture and immortalized corneal epithelial cell lines. All of them share limitations for their routine use. Using an improved protocol, we derived limbal epithelial cells from human induced pluripotent stem cells, named LiPSC, that are able to be passaged and differentiate further into corneal epithelial cells. Comparative RT-qPCR, immunofluorescence staining, flow cytometry analysis and zymography assays demonstrate that LiPSC are morphologically and molecularly similar to the adult stem cells. Moreover, contrary to HCE, LiPSC and primary limbal cells display similarly sensitive to cytotoxicity treatment among passages. Our data strongly suggest that LiPSC could become a powerful alternative cellular model for cosmetic and drug tests.

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Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals

Cited by 41 publications

References 10 publications

Human corneal cell culture models for drug toxicity studies

Human corneal cell culture models for drug toxicity studies

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

Induced pluripotent stem cell-derived limbal epithelial cells (LiPSC) as a cellular alternative for in vitro ocular toxicity testing

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